Leda Health Corp. is suing Washington state in federal court over the law, also known as House Bill 1564, which bars the sale and distribution of "over-the-counter sexual assault kits." But Washington Gov. Jay Inslee and Attorney General Robert Ferguson contended in a Friday filing that Leda has wrongly labeled the law an unconstitutional restriction on the company's free speech rights to market such kits, when the ban is really meant to shield Evergreen state residents from a harmful product that could deter them from seeking timely medical treatment for sexual assault.
"Courts routinely agree that laws like this one, banning the sale of harmful products — from tobacco to unapproved medications — do not limit speech," the state officials said in the opposition brief. "Leda's First Amendment challenge fundamentally mischaracterizes HB 1564 as banning marketing or speech about over-the-counter sexual assault kits. It does not."
With offices in New York and Pennsylvania, Leda offers an "early evidence kit" that allows sexual assault survivors to collect time-sensitive DNA themselves and submit it to a partner lab, then returns a report with the results. However, the company has ceased marketing and sales in Washington since receiving a cease-and-desist letter from Ferguson's office in October 2022.
Since filing the June 17 complaint against Inslee and Ferguson, the company has sought a preliminary injunction declaring HB 1564 unconstitutional. Leda argues lawmakers unfairly targeted it when crafting the legislation simply because they disagree with the company's mission to market the self-administered kit as an alternative to traditional reporting channels through law enforcement and the government.
Leda has also launched similar legal challenges against other state attorneys general who have sought to keep the kits off the market, including AGs in New York and Pennsylvania.
Urging the court to deny the injunction bid, the Washington state officials said the law was written and passed in 2023 with support from law enforcement, prosecutors, survivor advocates, university students and medical professionals. Proponents warned that at-home kits ultimately make criminal prosecutions more difficult and mislead survivors into forgoing exams by trained Sexual Assault Nurse Examiners who can perform proper forensic medical exams and provide trauma-informed treatment.
"While testing conducted and preserved by SANEs and law enforcement officers are regularly admitted into evidence, testing from at-home kits has never been successfully admitted into evidence in Washington," Inslee and Ferguson said. "With at-home kits, neither the witness who self-collects nor the individual who processes the results can establish an unbroken chain of custody as required to establish that test results are authentic and reliable."
While Leda has said it's illegally targeted by the law as the only company that sold such kits in Washington, the governor pointed to other companies that have considered offering self-administered kits, including Preserve Group, which sold them in New York and Oklahoma.
At most, the state contended, the law restricts commercial speech that's not covered by First Amendment protections because of the government's compelling interest in shielding sexual assault survivors from misinformation.
"Leda's nearly year-long delay in bringing its motion eviscerates any assertion that it urgently needs equitable relief," Inslee and Ferguson said. "And Washington has a significant interest in protecting survivors of sexual assault from deception, ensuring survivors receive timely treatment, and holding perpetrators accountable through the careful collection of evidence."
Leda has maintained its product helps sexual assault survivors who might avoid the traditional rape kit process because of privacy or safety concerns or distrust of law enforcement. The company has also pointed to the disclosures on its website saying it cannot guarantee any kit results will be admissible in court.
Alex Little of Litson PLLC, representing Leda, says the state's response "only highlights the problems with the law, which bars advocates from providing survivors with alternates to a system that has repeatedly failed them."
"When the Attorney General claims that helping survivors collect evidence at home is like selling guns and cigarettes to minors, it shows the weakness of their defense," Little said in an email to Law360.
A spokesperson for Inslee's office declined to comment Thursday.
Leda Health is represented by Jeffrey B. Coopersmith of Corr Cronin LLP and Alex Little, Zachary C. Lawson and John R. Glover of Litson PLLC.
The state is represented by Cristina Sepe, Tera M. Heintz and Lucy Wolf of the Washington State Attorney General's Office.
--Editing by Alex Hubbard.
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